Business Operations Associate - Site And Ssu Specialist
ICON plc
Tokyo, Japan
Not specified; competitive salary mentioned; benef...
Bachelor's degree in life sciences
2+ years clinical research experience
Study start-up activity experience
The role involves leading the preparation and submission of regulatory documents including clinical trial applications and ethics committee submissions
Job Summary
The role involves leading the preparation and submission of regulatory documents including clinical trial applications and ethics committee submissions.
ICON fosters an inclusive environment driving innovation and excellence to shape the future of clinical development.
The company offers competitive benefits including health insurance, retirement planning, and a global employee assistance program.
Matching Summary
The role involves leading the preparation and submission of regulatory documents including clinical trial applications and ethics committee submissions.
Salary
Not specified; Competitive salary mentioned; Benefits include annual leave, health insurance, and retirement planning
Skills & Requirements
Must-have
Bachelor's degree in life sciences
2+ years clinical research experience
Study start-up activity experience
ICH-GCP and local regulatory knowledge
Regulatory document submission skills
Nice-to-have
Process improvement initiative participation
Cross-functional team collaboration
Strong project management skills
Excellent communication abilities
Key Requirements
Bachelor's degree in life sciences or related field
Minimum 2 years experience in clinical research or regulatory affairs
Specific experience in study start-up activities
Deep understanding of ICH-GCP and local regulatory requirements